Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic GERD

Condition(s) targeted: Gastroesophageal Reflux

Intervention: pantoprazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth

To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Treatment-Withdrawal Study of the Efficacy and Safety of Pantoprazole Sodium Enteric-Coated Granules in Infants (1 Through 11 Months) With Symptomatic GERD.

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To assess the efficacy of pantoprazole in infants. The difference in withdrawal rates will be compared between the treatment and placebo groups.

Minimum age: N/A. Maximum age: 11 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- term or post term infants beyond the neonatal period of an age greater than 28 days

but less than or equal to 11 months

- clinical diagnosis of GERD

- weight greater than 2. 5 kg and less than or equal to 15 kg

Exclusion Criteria:

- known history of upper GI anatomic disorders

- history of acute life-threatening medical conditions

- clinically significant medical conditions or laboratory abnormalities

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Starting date: September 2006
Ending date: November 2007
Last updated: December 18, 2007